Tornier Perform MWE413Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700386974441), received between Jul 6, 2020 and Mar 29, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE M40 CORTILOC TRIAL BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN PLACED A THREADED GUIDE WIRE INTO THE PIECE TO PULL IT OUT OF THE PATIENTS GLENOID. IT WAS SUCCESSFULLY REMOVED. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13938596 ↗
• MalfunctionJan 6, 2022Break; Break

  IT WAS REPORTED THAT THE TRIAL BROKE WHEN THE SURGEON WAS REMOVING THE TRIAL. IT BROKE AGAINST THE POSTERIOR RETRACTOR. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13182465 ↗
• InjuryJul 6, 2020Material Fragmentation; Material Fragmentation

  THE INFERIOR POSTERIOR (IN A LEFT SHOULDER) PERIPHERAL PEG BROKE OFF AND STAYED IN THE GLENOID WHEN THE TRIAL WAS REMOVED. IN THE PROCESS TO RETRIEVE THE PEG FROM THE GLENOID, THE INFERIOR POSTERIOR QUADRANT OF THE GLENOID BROKE OFF AND DR (B)(6) HAD TO CONVERT FROM AN ANATOMIC TO A REVERSE DUE TO THE LOSE OF GLENOID BONE. SURGERY WAS COMPLETED BY SWITCHING TO PERFORM A REVERSE SHOULDER ARTHROPLASTY. THE PATIENT REQUIRED A REVERSE INSTEAD OF AN ANATOMIC SHOULDER. IT ADDED 45 MINUTES TO THE CASE AND ULTIMATELY MADE DR (B)(6) SWITCH FROM AN ANATOMIC TO A REVERSE ARTHROPLASTY.

  Patient problems: Bone Fracture(s); Device Embedded In Tissue or Plaque

  MAUDE report 10232167 ↗